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MetriCide OPA Plus Solution Test Strips are chemical indicators for use in determining whether the concentration of ortho-phthalaldehyde, the active ingredient in MetriCide OPA Plus Solution, is above or below the Minimum Recommended Concentration (MRC) of 0.3% established for MetriCide OPA Plus Solution.

The MetriCide™ OPA Plus Solution Test Strip is for use with MetriCide™ OPA Plus ortho-Phthaldehyde (OPA) High Level Disinfectant (HLD) solution which contains 0.6% MetriCide™ as the active ingredient. The test strip is an OPA concentration indicator that was developed for another OPA HLD solution. The test strip consists of an impregnated paper pad attached to a polymer substrate (which serves as the handle) - the test strip is evaluated by looking at the color of the pad at the stated read time. In essence, the test strip, following immersion in the test solution for a specified time period (1 second), will change from a start color to an endpoint color in a manner that is dependent on the concentration of the active (OPA); the test strip is read at a specified time interval (90 seconds).

The MetriCide™ OPA Plus Solution Test Strip is a chemical indicator designed to determine if the concentration of ortho-phthalaldehyde (OPA), the active ingredient in MetriCide™ OPA Plus Solution, is above or below the Minimum Recommended Concentration (MRC) of 0.3%.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the numerical sample size used for the test set for each specific test (Performance Characterization, Shelf Life, Analytic Specificity, Contaminants Testing). However, it implies that multiple strips were tested for each condition.

The data provenance is not specified regarding country of origin or whether the study was retrospective or prospective. It is implied that these are lab-based, controlled studies conducted by STERIS Corporation to verify the performance characteristics of the device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This type of device (chemical indicator test strip) does not typically involve human experts to establish ground truth in the same way an image-based diagnostic AI device would. The "ground truth" for the test strip is the actual, known concentration of OPA in the solutions used for testing (e.g., 0.45% OPA, 0.3% OPA, tap water, contaminated 0.3% OPA). These concentrations would be established through laboratory analytical methods (e.g., spectrophotometry, titration) which are considered objective and do not rely on expert interpretation in the same manner as clinical imaging. Therefore, this section is not applicable in the context of this device.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the ground truth is established by objective chemical analysis of the test solutions, not by expert interpretation requiring adjudication. The "reading" of the test strip is a visual color change which is then compared against a documented reference.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study is specifically relevant for human-in-the-loop AI systems where human readers interpret medical images or data. The MetriCide™ OPA Plus Solution Test Strip is a standalone chemical indicator that produces a visual color change for direct interpretation, not an AI system.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

This device is fundamentally a "standalone" chemical indicator that provides a direct visual result. It is not an algorithm, nor does it involve human interpretation beyond reading the color change against a reference. The performance testing outlined in the document (Table 2) reflects the standalone performance of the test strip itself.

7. The Type of Ground Truth Used

The ground truth used for the performance testing was based on:

• Known chemical concentrations: Solutions with precisely defined OPA concentrations (e.g., 0.45% OPA, 0.3% OPA, 0% OPA for tap water) and contaminated OPA solutions. These concentrations are established through laboratory analytical methods.
• Absence of contaminants: For the Contaminants Testing, the ground truth is that certain solutions were intentionally contaminated, while others (like the 0.45% OPA solution for performance characterization) are presumed to be uncontaminated.

8. The Sample Size for the Training Set

Not applicable. This device is a chemical indicator, not an AI/ML algorithm that requires a "training set" in the traditional sense. The test strip's design and chemical formulations are developed through research and development, but there isn't a "training set" of data used to "train" the device to perform its function.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As mentioned above, there is no "training set" for this type of device.

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